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Does Hyperbaric Oxygen Therapy Attenuate Secondary Hyperalgesia Areas Induced by a Thermal Injury in Human Volunteers?

Does Hyperbaric Oxygen Therapy Attenuate Secondary Hyperalgesia Areas Induced by a Thermal Injury in Human Volunteers? A Randomized Controlled Cross-over Study with a Blinded Observer.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-003858-14-DK
Enrollment
Unknown
Registered
2014-09-23
Start date
2014-12-01
Completion date
Unknown
Last updated
2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Experimental Inflammation MedDRA version: 17.1 Level: PT Classification code 10057480 Term: Hyperbaric oxygen therapy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Conoxid 100%, Medicinsk Oxygen, Kryogen Product Name: Medicinsk Oxygen Pharmaceutical Form: Medicinal gas, cryogenic INN or Proposed INN: OXYGEN CAS Number: 007782-44-7 Concentration unit:

Sponsors

Multidisciplinary Pain Center 7612, Rigshospitalet
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Healthy male volunteers Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Lack of ability to equalize pressure in the inner ear

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the effect of hyperbaric oxygen on experimental inflammation in a blinded study;Secondary Objective: Pain reduction;Primary end point(s): Preconditioning and a reduction in secondary hyperalgesia.;Timepoint(s) of evaluation of this end point: After completing statistical analysis.

Secondary

MeasureTime frame
Secondary end point(s): Pain reduction;Timepoint(s) of evaluation of this end point: After completing statistical analysis.

Countries

Denmark

Contacts

Public ContactHyperbaric Unit

Hyperbaric Unit, Department of Anaesthesiology, Dept. 4231, Rigshospitalet

anna.mygind.damgaard@regionh.dk004523248933

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026